RESCON- dexchlorpheniramine maleate and pseudoephedrine hydrochloride tablet, multilayer

Rescon by

Drug Labeling and Warnings

Rescon by is a Otc medication manufactured, distributed, or labeled by Capellon Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (per tablet)

Dexchlorpheniramine Maleate 2 mg

Pseudoephedrine Hydrochloride 60 mg

Purpose

Dexchlorpheniramine Maleate Antihistamine

Pseudoephedrine Hydrochloride Nasal Decongestant

Uses

For the temporary relief of

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes due to hay fever or other upper respiratory allergies
• nasal congestion

Temporarily helps

• clear nasal passages
• shrink swollen membranes

Warnings

• Do not exceed recommended dosage
• May cause excitability especially in children

• May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

When using this product

• Avoid alcoholic beverages
• Use caution when driving a motor vehicle or operating machinery.

Do not use

• If you have a breathing problem such as emphysema or chronic bronchitis
• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Stop use and ask a doctor

• If nervousness, dizziness, or sleeplessness occur.
• If symptoms do not improve within 7 days or are accompanied by fever.

Ask a doctor before use if you have

• glaucoma
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland
• or if you are taking sedatives or tranquilizers

If pregnant or breast feeding

Ask a health professional before use.

Keep out of the reach of children

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

• Adults (12 and older): One tablet every 4 to 6 hours. Not to exceed 4 doses in 24 hours.
• Children under 12 years of age: Consult a physician.

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredient

colloidal silicon dioxide, crospovidone polyplasdone, D&C Red #30, D&C Yellow #10, FD&C Blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone

Questions or Comments?

Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: 90 ct product label

INGREDIENTS AND APPEARANCE

RESCON 
dexchlorpheniramine maleate and pseudoephedrine hydrochloride tablet, multilayer

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64543-097
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N)	DEXCHLORPHENIRAMINE MALEATE	2 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	yellow, purple	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	RES11
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64543-097-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2012
2	NDC: 64543-097-02	1 in 1 POUCH; Type 0: Not a Combination Product	03/30/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/30/2012

Labeler - Capellon Pharmaceuticals, LLC (124568093)